The correct date should always be set because the date and time for the analysis are stored and displayed in
the patient and control records.The date format is YYYY:MM:DD, where YYYY is the year, MM is the month
(01 to 12), and DD is the day (01 to 31).
The correct time should always be set because the date and time for the analysis are stored and displayed in
the patient and control records.The time format is hh:mm, where hh is the hour from 00 to 23 and mm is
minutes from 00 to 59.
Enter today's date.
to confirm and
The screen contrast can be adjusted.
The screen must be realigned if the buttons do not respond accurately when touched. It is not necessary to
align screen as a part of the initial configuration.
screen contrast setting.
Adjust screen contrast by
and return to previous view.
screen alignment function.
Tap the cross-hair object (+)
in the upper left corner using
a blunt pencil to be precise.
Repeat for the object appea-
ring in the lower right corner
and in the center of the screen.
The previous screen view will
One beep means that the test is completed and result displayed.Two beeps means that an information
or error code is displayed.The beeper volume can be adjusted. If adjusted to a minimum, no beep will
How to switch OFF the Analyzer
Switch off the Analyzer by pressing the ON/OFF button (Figure 1).
The Analyzer should be switched off after the end of a working day.
• When the power is turned off, a closing down procedure is initiated.The cartridge carriage will move
to a safe position and the display will be active a few seconds until the Analyzer shuts down.
The Analyzer can be switched off, or the power supply disconnected, without loss of stored results.
• The Analyzer can only be switched off when the cartridge chamber is empty and the lid is closed. If the
ON/OFF button is pressed and the lid is open, the message “Close lid” will appear on the screen.
beeper volume setting.
Adjust beeper volume by
Quality control testing should be done to confirm that your Afinion™ AS100 Analyzer System is working
properly and providing reliable results. Only when controls are used routinely and the values are within the
acceptable ranges can accurate results for patient samples be assured.
Controls recommended by Axis-Shield should be used for quality control of your the Afinion™ AS100
Analyzer System.These control kits contain control materials with established acceptable ranges for the
Afinion™ AS100 Analyzer System.
Consult the Package Insert that comes with each control kit for detailed instructions on handling
and storage of the control material.
To run a control, follow the procedure in the section “Testing procedures”, page 20-28.
The measured value should be within the acceptable range stated on the control vial label or in the control
package insert. If the control results are within the acceptable ranges, patient samples may be tested and
If the result obtained for a control is outside the acceptable limits, make sure that:
- The control vial has not passed its expiry date.
- The control vial has not passed its open vial expiry date.
- The control vial and Afinion™ Test Cartridges have been stored according to recommendations.
- There is no evidence of bacterial or fungal contamination of the control vial.
Correct any procedural error and re-test the control material. If no procedural errors are detected, it is
recommended to examine the laboratory’s quality control record to investigate the frequency of control
failures. Ensure that there is no trend in out-of-range quality control results. Re-test the control material
using a new control vial.
Patient results must be declared invalid when controls do not perform as expected. Contact your
customer service representative (1-877-4-Afinion or 1-877-423-4646) for advice before analyzing
Frequency of control testing
Controls should be analyzed:
- With each new shipment of Afinion™ test kits.
- With each new lot of Afinion™ test kits.
- Users with a low frequency of testing should analyze controls at least every 30 days.
- When training new operators in correct use of the Afinion™ AS100 Analyzer.
- Anytime an unexpected test result is obtained.
- After software upgrade of the Afinion™ AS100 Analyzer.
The controls should always be analyzed if an unexpected test result is obtained (see the Afinion™ test
Package Insert, section Test result reporting). If local, state and/or federal regulations require more frequent
testing of control materials, then quality control should be performed in compliance with these regulations.
Each laboratory site can benefit from establishing a quality control plan.The laboratory director should
determine whether additional testing is appropriate for their laboratory.